FEATURED EDITORIAL
Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.
- The Case Of The Half Pill: AI As Outsourcing Detective
- Five Raw Material Assumptions That Can Derail Your Outsourced Program
- Complete Response Letters For CGTs Share This Common Theme
- Your 7 Decisions To Make Before MES Configuration
- CDMOs Co-Author The RNA Ecosystem
- The Orange Book's Blind Spot: Process Stability And Capability
- Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
GUEST COLUMNISTS
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Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
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The Orange Book's Blind Spot: Process Stability And Capability
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
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Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
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DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
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Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
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FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
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CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
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August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
PHARMA OUTSOURCING WHITE PAPERS
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White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges
Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.
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Continuous Manufacturing For API Breakthroughs
Observe how a compound library, designed for chemical diversity and lead-like properties, uses advanced filtering to improve hit discovery, speed hit-to-lead development, and boost early-stage small molecule drug discovery.
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Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
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Streamlining ADC Development: Advantage Of An All-In-One Solution
Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.
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Antibody-Based Drug Discovery At The Speed Of Light
Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of the PentaMice® platform for targeted immunization, and the precision of single B cell screening.
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A Simple And Powerful Solution For Accelerating Dissolution
Many poorly soluble drugs fail not because of low solubility, but because they dissolve too slowly. Learn how focusing on dissolution rate can unlock absorption gains using simple strategies.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Formulation Development For Therapeutic Oligonucleotides
- Accelerating A Complex Global Cardiovascular Outcomes Trial Via Coordinated Execution
- Supporting An Oncology Company In A Treatment For A Rare Tumor
- Adapt Or Fail: The Urgency Of Pandemic Preparedness For Sterile Injectable Manufacturing
- Accelerated LVV Manufacturing Enabled By Platform Excellence
REPORTING
PRODUCTS & SERVICES
ON-DEMAND WEBINARS
- Solvent Recovery Systems For Sustainable Pharma Manufacturing
- Developing Custom GMP Lipids: A Patient-Driven Partnership
- Smarter Lead Selection And Faster Representative Material
- APAC Scaling AAV manufacturing to 1000 L: strategies for robust and reproducible production
- Scaling AAV Manufacturing To 1000 L: Strategies For Robust And Reproducible Production